A randomized, double-blind, placebo-controlled trial of fluticasone propionate for pediatric eosinophilic esophagitis.

Abstract

BACKGROUND & AIMS:

Eosinophilic esophagitis is an increasingly recognized disorder with distinctive endoscopic, histologic, and allergic features. Although several therapies are advocated, no placebo-controlled trials have been conducted. We aimed to determine the efficacy of swallowed fluticasone propionate (FP) in the treatment of eosinophilic esophagitis.

METHODS:

We conducted a randomized, double-blind, placebo-controlled trial of swallowed FP in pediatric patients with active eosinophilic esophagitis. Thirty-six patients were randomly assigned to receive either 880 mug of FP (21 patients) or placebo (15 patients) divided twice daily for 3 months. The primary end point was histologic remission, defined by a peak eosinophil count of </=1 eosinophil in all 400x fields in both the proximal and distal esophagus.

RESULTS:

Fifty percent of FP-treated patients achieved histologic remission compared with 9% of patients receiving placebo (P = .047). FP decreased esophageal eosinophil levels, with a more pronounced effect in nonallergic individuals (65.9 +/- 25.3 vs 1.4 +/- 1.1 eosinophils/high-power field in the proximal esophagus [P = .03] and 84.6 +/- 19.7 vs 19.6 +/- 12.9 eosinophils/high-power field in the distal esophagus [P = .04]). Resolution of vomiting occurred more frequently with FP than placebo (67% vs 27%; P = .04). FP-induced resolution of mucosal eosinophilia was associated with resolution of endoscopic findings, epithelial hyperplasia, younger age (P = .0003), shorter height (P = .002), and lighter weight (P = .02). Effective treatment with FP decreased the number of CD8(+) T lymphocytes and mast cells in both the proximal and distal esophagus (P < .05).

CONCLUSIONS:

Swallowed FP is effective in inducing histologic remission in eosinophilic esophagitis, with a more pronounced effect in nonallergic and younger individuals, especially in the proximal esophagus.

• Authors: Michael R Konikoff, Richard J Noel, Carine Blanchard, Cassie Kirby, Sean C Jameson, Bridget K Buckmeier, Rachel Akers, Mitchell B Cohen, Margaret H Collins, Amal H Assa'ad, Seema S Aceves, Philip E Putnam, Marc E Rothenberg
• Journal: Gastroenterology (Gastroenterology) Vol. 131 Issue 5 Pg. 1381-91 (Nov 2006) ISSN: 0016-5085 [Print] United States
• PMID: 17101314 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Androstadienes
• Fluticasone

Topics

• Adolescent
• Age Factors
• Androstadienes (therapeutic use)
• Body Height
• Body Weight
• CD8-Positive T-Lymphocytes (immunology)
• Child
• Child, Preschool
• Double-Blind Method
• Eosinophilia (drug therapy, immunology, pathology)
• Esophagitis (drug therapy, immunology, pathology)
• Female
• Fluticasone
• Humans
• Hyperplasia
• Infant
• Male